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Effect of self-administration versus provider-administered injection of subcutaneous depot medroxyprogesterone acetate on continuation rates in Malawi: a randomised controlled trial.
Burke, Holly M; Chen, Mario; Buluzi, Mercy; Fuchs, Rachael; Wevill, Silver; Venkatasubramanian, Lalitha; Dal Santo, Leila; Ngwira, Bagrey.
Afiliação
  • Burke HM; FHI 360, Durham, NC, USA. Electronic address: hburke@fhi360.org.
  • Chen M; FHI 360, Durham, NC, USA.
  • Buluzi M; College of Medicine, University of Malawi, Blantyre, Malawi.
  • Fuchs R; FHI 360, Durham, NC, USA.
  • Wevill S; FHI 360, Durham, NC, USA.
  • Venkatasubramanian L; FHI 360, Durham, NC, USA.
  • Dal Santo L; FHI 360, Durham, NC, USA.
  • Ngwira B; College of Medicine, University of Malawi, Blantyre, Malawi.
Lancet Glob Health ; 6(5): e568-e578, 2018 05.
Article em En | MEDLINE | ID: mdl-29526707
BACKGROUND: Injectable contraceptives are popular in sub-Saharan Africa but have high discontinuation rates due partly to the need for provider-administered re-injection. We compared continuation rates of women who self-injected subcutaneous depot medroxyprogesterone acetate (DMPA-SC) and women who received DMPA-SC from a health-care provider, including community health workers (CHWs). METHODS: We did an open-label randomised controlled trial based at six Ministry of Health clinics in rural Mangochi District, Malawi. Health-care providers recruited adult women who presented at the six clinics or to CHWs in rural communities in the clinic catchment areas. Participants received DMPA-SC and were randomised (1:1) to receive provider-administered injections or training in how to self-inject DMPA-SC. Randomisation was done via a computer-generated block randomisation schedule with block sizes of four, six, and eight and stratified by study site, generated by an independent statistician. Self-injectors administered the first injection under observation and were sent home with three doses, written instructions, and a calendar. The provider-administered group received a DMPA-SC injection and a calendar, and were asked to return for subsequent injections. Data collectors contacted participants after the 14-week re-injection window at 3, 6, and 9 months to collect continuation data. At 12 months after enrolment or early discontinuation, women had their final interview, which included pregnancy testing. The primary outcome was discontinuation of DMPA-SC, as assessed in the intention-to-treat population. We used Kaplan-Meier methods to estimate the probabilities of continuation and a log-rank test to compare groups. Safety was assessed in the as-treated population, which consisted only of participants who successfully received at least one DMPA-SC injection after randomisation. This trial is registered with ClinicalTrials.gov, number NCT02293694. FINDINGS: This study lasted from Sept 17, 2015, to Feb 21, 2017. 731 women underwent randomisation, with 364 assigned to the self-administered group and 367 to the provider-administered group. One woman in the self-injection group withdrew at month 0. Treatment was discontinued by 99 women in the self-administered group and 199 women in the provider-administered group. The 12 month continuation rate was 73% in the self-injection group and 45% in the provider-administered group, giving an incidence rate ratio of 0·40 (95% CI 0·31-0·51; p<0·0001). Adverse events deemed to potentially be treatment-related were reported by ten women (20 events) in the self-administered group and 17 women (28 events) in the provider-administered group. Five serious adverse events were reported during the trial by four women; two events related to DMPA-SC (menorrhagia and anaemia requiring hospital admission) were reported by the same woman in the provider-administered group and resolved without sequelae. The other serious adverse events, including one death, were deemed to be unrelated to DMPA-SC. INTERPRETATION: Women who self-injected DMPA-SC had significantly higher rates of continuation than those receiving provider-injected DMPA-SC. Community-based provision of injectable contraception for self-injection in low-resource settings seems to be safe and feasible. Self-administration of DMPA-SC should be made widely available. FUNDING: United States Agency for International Development and Children's Investment Fund Foundation.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Autoadministração / Acetato de Medroxiprogesterona / Serviços de Saúde Rural / Anticoncepcionais Femininos / Adesão à Medicação Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adolescent / Adult / Female / Humans País/Região como assunto: Africa Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Autoadministração / Acetato de Medroxiprogesterona / Serviços de Saúde Rural / Anticoncepcionais Femininos / Adesão à Medicação Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adolescent / Adult / Female / Humans País/Região como assunto: Africa Idioma: En Ano de publicação: 2018 Tipo de documento: Article